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Alpha-1 antitrypsin (AAT) for Graft-versus-Host Disease

University of Wisconsin, Madison, WI
Graft-versus-Host DiseaseAlpha-1 antitrypsin (AAT) - Biological
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial will compare the effectiveness of a combination of AAT and corticosteroids to corticosteroids alone as the first treatment for patients at high risk for developing acute GVHD.

Eligible Conditions
  • Graft-versus-Host Disease

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

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Steroid Therapy

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: up to 12 months post-randomization

28 days post-randomization
Percent of participants with complete or partial response to acute Graft-versus-Host Disease (GVHD) treatment
Day 7
Percent of participants with response
Day 56 post-randomization
Percent of participants with GVHD-free survival
Month 12
Duration of response (DOR)
Graft-vs-Host Disease
Percent of participants with disease relapse
Percent of participants with non-relapse mortality (NRM)
Percent of participants with overall survival and progression-free survival
Day 30
Percent of participants with Grade 2 to 3 systemic infections
Percent of participants with Grade 3 to 5 treatment-emergent adverse events (TEAEs)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Neihulizumab (AbGn-168H)
1
[18F]F-Ara-G
1
Steroid Therapy

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

AAT
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

136 Total Participants · 2 Treatment Groups

Primary Treatment: Alpha-1 antitrypsin (AAT) · Has Placebo Group · Phase 3

AAT
Biological
Experimental Group · 1 Intervention: Alpha-1 antitrypsin (AAT) · Intervention Types: Biological
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months post-randomization

Who is running the clinical trial?

Blood and Marrow Transplant Clinical Trials NetworkNETWORK
49 Previous Clinical Trials
13,905 Total Patients Enrolled
CSL BehringLead Sponsor
189 Previous Clinical Trials
1,210,672 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,611,077 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,674 Previous Clinical Trials
47,133,815 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
National Cancer Institute (NCI)NIH
13,274 Previous Clinical Trials
41,234,583 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Study DirectorStudy DirectorCSL Behring
1,104 Previous Clinical Trials
481,510 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The type of transplant or donor source or the intensity of treatment used in a previous transplant is not important.
References

Frequently Asked Questions

Has AAT been cleared by the FDA for therapeutic use?

"There is some evidence for AAT's efficacy and it has undergone multiple rounds of testing, so it has been deemed safe and given a score of 3." - Anonymous Online Contributor

Unverified Answer

Can patients still sign up for this program?

"The listed clinical trial on clinicaltrials.gov is still recruiting patients. This trial was originally posted on 2020-01-09 and was most recently updated on 2022-08-12." - Anonymous Online Contributor

Unverified Answer

How many individuals are being treated in this clinical trial?

"The study requires a total of 122 participants that fit the inclusion criteria. The sponsor, CSL Behring, will administer the trial from their locations in Richmond, Virginia and Ann Arbor, Michigan." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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